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Trial registered on ANZCTR


Registration number
ACTRN12613000984796
Ethics application status
Approved
Date submitted
31/08/2013
Date registered
4/09/2013
Date last updated
13/04/2021
Date data sharing statement initially provided
13/04/2021
Date results provided
13/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The relative efficacy of codeine 60mg four times daily in improving analgesia for patients following mandibular third molar surgery when augmented to paracetamol 1000mg four times daily and ibuprofen 400mg three times daily: a pilot, double-blind randomized control trial.
Scientific title
In patients who have had mandibular wisdom teeth surgically removed, does the addition of codeine 60mg four times daily to paracetamol 1000mg four times daily and ibuprofen 400mg three times daily, compared to paracetamol 1000mg four times daily and ibuprofen 400mg three times daily alone, improve pain relief?
Secondary ID [1] 283121 0
nil
Universal Trial Number (UTN)
U1111-1142-1254
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain following mandibular third molar surgery. 289373 0
Condition category
Condition code
Surgery 289707 289707 0 0
Other surgery
Anaesthesiology 290365 290365 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group:
paracetamol 1000mg four times daily (qid) + ibuprofen 400mg three times daily (tds) + codeine phosphate 60mg qid.
Mode of administration is oral.
Duration of intervention is 48 hours following surgery.
Participants will be asked regarding their adherence to the prescribed drug regime as part of the post-operative questionnaire on day 3 following surgery.
Intervention code [1] 287332 0
Treatment: Drugs
Comparator / control treatment
Control group:
paracetamol 1000mg qid + ibuprofen 400mg tds + placebo.
Mode of administration is oral.
Duration of intervention is 48 hours following surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 289799 0
Level of pain. Measured using:
1) a visual analogue scale (VAS);
2) by means of a participant questionnaire
Timepoint [1] 289799 0
Each participant records their pain level on a VAS immediately before surgery, shortly after surgery (prior to leaving hospital), and then following surgery every 3 hours for the first 48 hours during awake hours. Each participant also fills out a questionnaire regarding level of pain prior to surgery and also on day 3 following surgery.
Secondary outcome [1] 303263 0
nil
Timepoint [1] 303263 0
nil

Eligibility
Key inclusion criteria
The patient must be aged 17 years or over.
There will be no discrimination (e.g. gender; race; ethnicity). Moreover, non-English speaking people will not be excluded; an accredited interpreter will be employed per required need.
Patient participation is entirely voluntary.
Patients must have been seen by a consultant oral and maxillofacial surgeon at the
University of Otago, or by one of their oral and maxillofacial surgery trainees, and be
deemed appropriate for participation in the present study by this clinician.
The patient must legitimately require at least the removal of one or both of their mandibular third molars.
Expected bone removal for extraction of the mandibular third molar(s).
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients under 17 years of age are not eligible for participation in this research project. This is to provide a safeguard around the level of drug doses used.

The patient must not have any of the following conditions or reasons which contraindicate or caution the use of paracetamol, ibuprofen, or codeine, as described in the latest edition of MIMS New Ethicals:
Anyone who needs to drive a motor vehicle or operate machinery within the 48 hour period following surgery
NSAID-sensitive asthma
Active gastrointestinal bleeding or ulceration
Bleeding disorder
Patients on anticoagulants P
Renal impairment
Hepatic impairment
Cardiovascular disease
Systemic lupus erythematosus
Patients on hepatic enzyme inducers (e.g. certain anticonvulsants)
Pregnancy and lactation
Respiratory depression; COPD
Raised intracranial pressure
Alcoholism
Opioid addiction
Patients on CNS depressants
G-6-PD deficiency
Hypersensitivity to morphine

Furthermore, the patient must not have any of the following conditions or reasons which contraindicate or caution the use of midazolam or dexamethasone, as described in the latest edition of MIMS New Ethicals:
Hypersensitivity to benzodiazepines
Myasthenia gravis
Glaucoma
Systemic viral, bacterial, or fungal infection
Osteoporosis
Psychosis

Finally, the patient must not have a contraindication to either intravenous sedation or general anaesthetic.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will enrol at the School of Dentistry via routine enrolment procedures in order to receive treatment. Subjects who choose to participate in the study are seen in the Department of Oral Diagnostic and Surgical Sciences and enrol in the study by filling out a written consent form.
Allocation concealment procedures is by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data upon which to undertake a power analysis are scarce. However, for an anticipated effect size of 0.5, an a value of 0.05 and a power of 0.8 to detect a difference, the estimated number per group is 51.
That is, 102 human subjects divided into two groups:
Control group: 51 participants
Intervention group: 51 participants

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/11/2013
Actual
4/11/2013
Date of last participant enrolment
Anticipated
Actual
30/06/2014
Date of last data collection
Anticipated
Actual
5/12/2014
Sample size
Target
102
Accrual to date
Final
131
Recruitment outside Australia
Country [1] 5349 0
New Zealand
State/province [1] 5349 0

Funding & Sponsors
Funding source category [1] 287872 0
University
Name [1] 287872 0
Department of Oral Diagnostic and Surgical Sciences, of the School of Dentistry, at the University of Otago.
Country [1] 287872 0
New Zealand
Primary sponsor type
University
Name
Head of the Department of Oral Diagnostic and Surgical Sciences
Address
Faculty of Dentistry, University of Otago, PO Box 647, Dunedin 9054.
Country
New Zealand
Secondary sponsor category [1] 286599 0
University
Name [1] 286599 0
Health Research South (University of Otago)
Address [1] 286599 0
Health Research South
PO Box 56
Dunedin 9054
Country [1] 286599 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289814 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 289814 0
Ethics committee country [1] 289814 0
New Zealand
Date submitted for ethics approval [1] 289814 0
Approval date [1] 289814 0
08/05/2013
Ethics approval number [1] 289814 0
13/STH/35
Ethics committee name [2] 289815 0
University of Otago Human Ethics Committee
Ethics committee address [2] 289815 0
Ethics committee country [2] 289815 0
New Zealand
Date submitted for ethics approval [2] 289815 0
Approval date [2] 289815 0
12/06/2013
Ethics approval number [2] 289815 0
13/080

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40746 0
A/Prof Rohana De Silva
Address 40746 0
Department of Oral Diagnostic and Surgical Sciences
Faculty of Dentistry
PO Box 647
University of Otago
Dunedin 9054
Country 40746 0
New Zealand
Phone 40746 0
+64 3 479 7036
Fax 40746 0
Email 40746 0
rohana.kumara@otago.ac.nz
Contact person for public queries
Name 40747 0
Rohana De Silva
Address 40747 0
Department of Oral Diagnostic and Surgical Sciences
Faculty of Dentistry
PO Box 647
University of Otago
Dunedin 9054
Country 40747 0
New Zealand
Phone 40747 0
+64 3 479 7036
Fax 40747 0
Email 40747 0
rohana.kumara@otago.ac.nz
Contact person for scientific queries
Name 40748 0
Rohana De Silva
Address 40748 0
Department of Oral Diagnostic and Surgical Sciences
Faculty of Dentistry
PO Box 647
University of Otago
Dunedin 9054
Country 40748 0
New Zealand
Phone 40748 0
+64 3 479 7036
Fax 40748 0
Email 40748 0
rohana.kumara@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.